A 12-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05244)

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00704444

Collaborator

Bayer (Industry)

11,332

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 12-week period. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia Familial Hypercholesterolemia Homozygous Sitosterolemia	Drug: Ezetimibe Drug: Ezetimibe + other lipid-lowering medication(s)

Detailed Description

The population will be selected from 2,000 institutions in Japan.

Study Design

Study Type:

Observational

Actual Enrollment :

11332 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Designated Drug Use Investigation (12 Weeks) of Zetia 10mg Tablets - A 12-Week Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Zetia monotherapy Patients to be treated with Zetia alone (10-mg tablets,) for hypercholesterolemia	Drug: Ezetimibe Ezetimibe, 10-mg tablets Other Names: Zetia
Zetia combination therapy Patients to be treated with Zetia (10-mg tablets,) in combination with other lipid-lowering drugs for hypercholesterolemia	Drug: Ezetimibe + other lipid-lowering medication(s) Ezetimibe, 10-mg tablets + other lipid-lowering medication(s), as prescribed by attending physician Other Names: Zetia + other lipid-lowering medication(s)

Arm

Intervention/Treatment

Zetia monotherapy

Patients to be treated with Zetia alone (10-mg tablets,) for hypercholesterolemia

Drug: Ezetimibe

Ezetimibe, 10-mg tablets

Other Names:

Zetia

Zetia combination therapy

Patients to be treated with Zetia (10-mg tablets,) in combination with other lipid-lowering drugs for hypercholesterolemia

Drug: Ezetimibe + other lipid-lowering medication(s)

Ezetimibe, 10-mg tablets + other lipid-lowering medication(s), as prescribed by attending physician

Other Names:

Zetia + other lipid-lowering medication(s)

Outcome Measures

Primary Outcome Measures

Incidence of adverse events [Adverse events will be monitored throughout the 12-week period. (Subjects who discontinue Zetia treatment during the 12-week period will be investigated up to the time of therapy discontinuation )]
Change in LDL-C [LDL-C at start of 12 weeks will be compared to LDL-C at the end of the 12-week period.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects who have hypercholesterolemia, familial hypercholesterolemia, or homozygous sitosterolemia will be considered for this study.

Zetia monotherapy patients must be treated with Zetia alone.

Zetia combination therapy patients must be treated with Zetia in combination with other lipid-lowering drugs for hypercholesterolemia.

Exclusion Criteria:

Patients with a history of hypersensitivity to any ingredient in Zetia
Patients with serious hepatic function disorder should not be treated with Zetia in combination with an HMG-CoA reductase inhibitor.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Organon and Co
Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Organon and Co

ClinicalTrials.gov Identifier:

NCT00704444

Other Study ID Numbers:

P05244

First Posted:

Jun 25, 2008

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Additional relevant MeSH terms:

Hyperlipoproteinemia Type II

Hypercholesterolemia

Ezetimibe

Study Results

No Results Posted as of Feb 16, 2022